Background Clinically relevant postoperative pancreatic fistulas (CR-POPF) are serious inherent risks of pancreatic resection. Preoperative CR-POPF risk assessment is currently inadequate and rarely ...disqualifies patients who need resection. The best evaluation of risk occurs intraoperatively, and should guide fistula prevention and response measures thereafter. We sought to develop a risk prediction tool for CR-POPF that features intraoperative assessment and reveals associated clinical and economic significance. Study Design Based on International Study Group of Pancreatic Fistula classification, recognized risk factors for CR-POPF (small duct, soft pancreas, high-risk pathology, excessive blood loss) were evaluated during pancreaticoduodenectomy. An optimal risk score range model, selected from 3 different constructs, was first derived (n = 233) and then validated prospectively (n = 212). Clinical and economic outcomes were evaluated across 4 ranges of scores (negligible risk, 0 points; low risk, 1 to 2; intermediate risk, 3 to 6; high risk, 7 to 10). Results Clinically relevant postoperative pancreatic fistulas occurred in 13% of patients. The incidence was greatest with excessive blood loss. Duct size <5 mm was associated with increased fistula rates that rose with even smaller ducts. These factors, together with soft pancreatic parenchyma and certain disease pathologies, afforded a highly predictive 10-point Fistula Risk Score. Risk scores strongly correlated with fistula development (p < 0.001). Notably, patients with scores of 0 points never developed a CR-POPF, while fistulas occurred in all patients with scores of 9 or 10. Other clinical and economic outcomes segregated by risk profile across the 4 risk strata. Conclusions A simple 10-point Fistula Risk Score derived during pancreaticoduodenectomy accurately predicts subsequent CR-POPF. It can be readily learned and broadly deployed. This prediction tool can help surgeons anticipate, identify, and manage this ominous complication from the outset.
Background The Fistula Risk Score (FRS) is a clinical tool developed from single-institutional data using primarily intraoperative factors to characterize the risk of clinically relevant pancreatic ...fistula (CR-POPF) after pancreaticoduodenectomy. We developed a modified FRS based on objective, nationally accrued data that is more readily determined before resection. Study Design The 2012 NSQIP Pancreatic Demonstration Project (PDP) was used to identify 1,731 pancreaticoduodenectomy resections over 14 months (2011 to 2012). A randomly generated 70% cohort was used for model development, and the remaining 30% for internal validation. Univariate analysis was used to identify predictors of CR-POPF. Variables with a value of p < 0.1 were included in multivariable modeling. Results Five significant predictors of CR-POPF were identified and assigned points based on odds ratios: sex, BMI, preoperative total bilirubin, pancreatic ductal diameter, and gland texture. The 10-point model was further applied to the 2014 PDP for external validation. In the testing group, risk scores of 0 to 2 (negligible risk), 3 to 6 (low risk), 7 to 8 (intermediate risk), and 9 to 10 (high risk) were associated with CR-POPF rates of 0%, 6.7%, 16.4%, and 33.7%, respectively. Similar values were seen using the internal validation cohort: 0%, 6.3%, 13.5%, and 31.0%, respectively. The external validation values were 2.9%, 10.2%, 16.4%, and 25.8%, respectively. Conclusions This modified FRS allows for estimation of CR-POPF risk using preoperative and easily determined intraoperative factors, and will allow comparison of performance data for individual surgeons to national norms, improved perioperative counseling, and potential for scrutinizing and/or implementing interventions designed to decrease CR-POPF rates.
Background A recent randomized trial used the Fistula Risk Score (FRS) to develop guidelines for selective drainage based on clinically relevant fistula (CR-POPF) risk. Additionally, postoperative ...day (POD) 1 drain and serum amylase have been identified as accurate postoperative predictors of CR-POPF. This study sought to identify patients who may benefit from selective drainage, as well as the optimal timing for drain removal after pancreatoduodenectomy. Study Design One hundred six pancreatoduodenectomies from a previously reported RCT were assessed using risk-adjustment. The incidence of CR-POPF was compared between FRS risk cohorts. Drain and serum amylase values from POD 1 were evaluated using receiver operating characteristic (ROC) analysis to establish cut-offs predictive of CR-POPF occurrence. A regression analysis compared drain removal randomizations (POD 3 vs POD 5). Results Three-quarters of patients had moderate/high CR-POPF risk. This group had a CR-POPF rate of 36.3% vs 7.7% among negligible/low risk patients (p = 0.005). The areas under the ROC curve for CR-POPF prediction using POD 1 drain and serum amylase values were 0.800 (p = 0.000001; 95% CI 0.70–0.90) and 0.655 (p = 0.012; 95% CI 0.55–0.77), respectively. No significant serum amylase cut-offs were identified. Moderate/high risk patients with POD 1 drain amylase ≤5,000 U/L had significantly lower rates of CR-POPF when randomized to POD 3 drain removal (4.2% vs 38.5%; p = 0.003); moreover, these patients experienced fewer complications and shorter hospital stays. Conclusions A clinical care protocol is proposed whereby drains are recommended for moderate/high FRS risk patients, but may be omitted in patients with negligible/low risk. Drain amylase values in moderate/high risk patients should then be evaluated on POD 1 to determine the optimal timing for drain removal. Moderate/high risk patients with POD 1 drain amylase ≤5,000 U/L have lower rates of CR-POPF with POD 3 (vs POD ≥ 5) drain removal; early drain removal is recommended for these patients.
Background Hospital readmission is under increased scrutiny as a quality metric for surgical performance, yet its relevance after elective, high-acuity operations is poorly understood. We sought to ...define the clinical nature and economic impact of readmission after major pancreatic resection. Study Design From 2001 to 2009, 578 pancreatic resections followed standardized perioperative care. Clinical and economic outcomes were evaluated and predictors of readmission were identified by regression analysis. Results One hundred and eleven (19%) patients required readmission within 30 days (median 8 days post discharge), with only 12 more readmitted between 31 and 90 days. Twenty-three (21%) patients were readmitted multiple times. Reasons for readmission were procedure-specific complications (48%), general postoperative complications/infections (18.0%), failure to thrive (12%), or medical problems (9%). An additional 14% were readmitted solely for diagnostic evaluation of symptoms without cause. Neither preoperative demographics/acuity nor intraoperative factors influenced readmission. Instead, readmission was predicted by any (odds ratio = 2.24) or major (odds ratio = 2.19) complications, and clinically relevant (odds ratio = 5.05) or latent (odds ratio = 4.04) pancreatic fistula. Patient survival was negatively, but not significantly, associated with readmissions. Overall hospital stay and costs were markedly affected by readmission, as readmitted patients cost an average of $16,000 more. Conclusions In this practice-based analysis, readmissions after pancreatic resection were frequent, early, costly, and largely related to procedure-specific complications. As initial hospital stay continues to decline in high-acuity surgery, readmissions might be required for optimal management of complications, which often manifest later in the recovery course. Clinical pathway deviations predict potential readmissions, and might prompt adjustments in management and disposition of patients at risk for returning to the hospital.
Background Although clinical pathways were developed to streamline patient care cost efficiently, few have been put to rigorous financial test. This is important today, because payors demand clear ...solutions to the cost-quality puzzle. We describe a novel, objective, and versatile model that can evaluate and link the clinical and economic impacts of clinical pathways. Study Design Outcomes for 209 consecutive patients undergoing high-acuity surgery (pancreaticoduodenectomy), before and after pathway implementation, were examined. Four grades of deviation (none to major) from the expected postoperative course were defined by merging length of stay with a validated classification scheme for complications. Deviation-based cost modeling (DBCM) links these deviations to actual total costs. Results Clinical outcomes compared favorably with benchmark standards for pancreaticoduodenectomy. Despite increasing patient acuity, this new pathway shortened length of stay, reduced resource use, and decreased hospital costs. DBCM indicated that fewer deviations from the expected course occurred after pathway implementation. The impacts of complications were less severe and translated to an overall cost savings of $5,542 per patient. DBCM also revealed that as more patients migrated to the expected course within our standardized care path, 50% of overall cost savings ($2,780) was attributable to the pathway alone, and improvements in care over time (secular trends) accounted for the remainder. Conclusions DBCM accurately determined the incremental contribution of clinical pathway implementation to cost savings beyond that of secular trends alone. In addition, this versatile model can be customized to other systems’ improvements to reveal their true clinical and economic impacts. This is valuable when choices linking quality with cost must be made.
Background The Physiologic and Operative Severity Score for the enUmeration of Mortality and Morbidity (POSSUM) is a predictive scoring system for postoperative morbidity. While numerous studies ...validate its application to major abdominal surgery, few exclusively consider pancreatic resections, whose unique complications are costly and problematic. We examined whether POSSUM could accurately reflect clinical and economic outcomes in pancreatic resection. Methods 326 consecutive pancreatic resections (227 pancreaticoduodenectomies, 87 distal, 7 central, and 5 total pancreatectomies) were performed between October 2001 and January 2007. POSSUM score was prospectively calculated for each case, and patients were stratified to quintiles of morbidity risk: ≤ 20%, 20-40%, 40-60%, 60-80%, ≥ 80%. Actual clinical and economic outcomes were compared across the groups. Predictive risk assessment was further evaluated independently within each resection type. Logistic regression analysis was performed to identify specific POSSUM parameters predictive of postoperative morbidity. Results Observed and Expected morbidity rates were equivalent (53.1% vs 55.5%) with an overall O/E ratio of 0.96. Although no patients presented with POSSUM scores below 20%, a relatively equal distribution was assigned to the remaining risk cohorts. Clinical and economic outcomes progressively worsened with escalations in POSSUM scores. Increasing morbidity risk was associated with significantly longer hospital stays, higher rates of complications, and more blood transfusions, ICU management, and discharge to rehabilitation facilities. This had considerable economic impact, as mean hospital costs rose from $19,951 in the 20-40% risk cohort, to $31,281 in the ≥ 80% group. Breakdown by operation type demonstrates that POSSUM definitively predicts morbidity following both proximal and distal resection, but more accurately forecasts the need for ICU management and rehabilitation placement when pancreatoduodenectomy is performed. Multivariate analysis revealed that one-half of POSSUM parameters were significant contributors for postoperative morbidity, with age, preoperative hemoglobin concentration, and intraoperative blood loss demonstrating the strongest correlations. Conclusion POSSUM is a valuable perioperative scoring system for evaluating variance in pancreatic surgical methods and outcomes, and can be employed to guide management decisions that impact postoperative recovery.
Background In 2006, the Sendai Consensus Guidelines identified size >3.0 cm as the only independent predictor of malignancy in incidentally discovered pancreatic cysts. The 2012 updated guidelines ...increased emphasis on radiographic features over size. Earlier studies included patients with preoperatively diagnosed carcinoma or with a corresponding mass. In this report, we characterize the use of size and serum tumor markers in the initial evaluation of pancreatic cystic neoplasms without preoperatively diagnosed adenocarcinoma and correlate them with clinical and pathologic outcomes. Study Design A retrospective cohort study was undertaken of 112 patients with a resected pancreatic cystic neoplasm. Patient demographics, cyst characteristics, preoperative serum tumor markers, morbidity, and mortality were captured. Statistical analysis included nonparametric tests of comparison, multivariate logistic regression, and receiver operating characteristic curve analyses. Results One hundred and twelve pancreatic cystic neoplasms were resected; there was one perioperative death. Mucinous cysts were common (78%), followed by serous cysts (13%). In total, 17% of cysts harbored malignancy. On multivariate analysis, the risk of malignancy in cysts ≥3 cm was more than 4 times that of smaller cysts (relative risk (RR) = 4.32; 95% CI, 1.55–12.07). There was no significant difference in serum CEA, cancer antigen 19-9, or cyst-fluid CEA levels between the benign and malignant groups. At a median follow-up of 30 months, the incidence of diabetes was 15%. Conclusions Surgical resection of pancreatic cysts can be performed with low perioperative mortality and acceptable long-term morbidity. Use of cyst size as a rationale for resection of cystic lesion, as per the Sendai criteria, is justified.
Background In 2015, the American Gastroenterological Association (AGA) published guidelines to provide recommendations for management of suspected pancreatic cystic neoplasms (PCNs). The aim of this ...study was to compare efficacy of these with the Fukuoka consensus guidelines in predicting advanced neoplasia (AN) in patients with suspected PCNs. Study Design We performed a retrospective study of 239 patients who underwent surgical resection for suspected mucinous PCN at a tertiary care center from 2000 to 2014. Surgical pathology was the gold standard. The AGA and Fukuoka criteria were applied, and their performance in predicting AN, defined as invasive cancer or high-grade dysplasia (HGD), was assessed. Results Advanced neoplasia was found in 71 of 239 (29.7%) patients (28 invasive cancer, 43 HGD). The Fukuoka “high-risk” (FG-HR) and AGA “high-risk” (AGA-HR) criteria identified patients with AN with sensitivities of 28.2% and 35.2%, specificities of 95.8% and 94.0%, positive predictive values of 74.1% and 71.4%, and negative predictive values of 75.9% and 77.5%, respectively. Overall, there was no significant difference between the guidelines for prediction of AN. There were 7 and 6 cases with invasive cancer, and 23 and 24 cases with HGD missed by the FG-HR and AGA-HR guidelines, respectively. Conclusions In a retrospective analysis, the AGA guidelines are not superior to the Fukuoka guidelines in identifying AN in suspected PCNs. Both sets of guidelines have fair PPV for detection of AN, which would lead to avoidable resections in patients without AN. Additionally, the high-risk features of both guidelines do not accurately identify all patients with AN.
Background The interplay between baseline physiology, operative performance, and postoperative recovery is poorly defined. We describe the beneficial effect of a successful operation on outcomes ...across the full spectrum of physiologic risk for an elective high-acuity procedure. Study Design Four hundred twelve consecutive pancreatic resections, performed between 2001 and 2008, were analyzed according to the Physiologic and Operative Severity Score for the Enumeration of Mortality and Morbidity. Baseline physiology was classified according to the Physiologic Severity Score: minor (≤ 16); intermediate (17 to 23); vulnerable (≥ 24). Surgical performance was assigned by the Operative Severity Score: class I (≤ 14); class II (15 to 17); class III (≥ 18). Physiologic and operative predictions were independently correlated with actual clinical and economic outcomes and then merged to measure the influence of surgical performance beyond baseline physiology. Results As baseline physiology declines, patients suffer more complications and require more therapeutic and invasive interventions. Within each physiologic risk grade, class I operations (optimal surgical performances) were associated with lower rates of morbidity, shorter hospital stays, and improved cost efficiency. Deeper analysis reveals that intraoperative blood loss is the most variable and influential factor affecting physiologic risk. Each additional unit (375 mL) of blood loss increases the odds of morbidity by 45%, prolongs hospital stay by 1 day, and costs an additional $4,000 per patient. Conclusions Predictive risk assessment accurately demonstrates that escalating physiologic risk worsens postoperative morbidity, prolongs hospital duration, and increases costs after such high-acuity operations. These effects are attenuated by improved operative performance.
